Wound retractor device

ABSTRACT

A surgical device may include a wound retractor. The wound retractor may include a distal member, a proximal member, and a wound retracting sleeve extending between the distal member and the proximal member. The surgical device may also include a sealing assembly coupled to the wound retractor.

INTRODUCTION

The invention relates to a retractor. In particular the inventionrelates to a retractor for retracting the margins of an incision or anatural bodily orifice to provide maximum exposure of an organ or bodystructures for examination and/or access for surgical procedures, whilealso providing protection for the exposed sides of the incised tissue.

Various retractors are known. Some known retractors are difficult andcumbersome to use, and/or are relatively expensive. In addition, someknown retractors are limited to use with a particular size of incisionand a particular patient anatomy.

This invention is directed towards providing an improved wound retractorwhich will overcome at least some of these problems, and in additionprovide a means of wound protection during a surgical procedure.

STATEMENTS OF INVENTION

According to the invention there is provided a wound protector andretractor device comprising:

-   -   a longitudinal axis;    -   a distal member;    -   a proximal member; and    -   a sleeve extending at least between he distal member and the        proximal member,    -   the sleeve having a proximal gripping portion for pulling the        sleeve upwardly to shorten an axial extent located between the        distal member and the proximal member.

In the device, on release of the gripping portion the shortened axialextent between the distal member and the proximal member issubstantially maintained without a requirement for an additional lockingdevice.

In one embodiment the proximal gripping portion is provided at aproximal end portion of the sleeve. The gripping portion may bereinforced by a reinforcing arrangement such as a gripping ring. Thegripping ring may be mounted to the sleeve.

In one embodiment the sleeve is fixed to the proximal member at a firstend portion and is movable over the proximal member at a second endportion. The sleeve may be axially slidable over the proximal member atthe second end portion.

In another embodiment the second end portion of the sleeve is slidinglyreceived over a portion of the proximal member to allow relativemovement between the sleeve and the proximal member to shorten the axialextent of the sleeve located between the distal member and the proximalmember. The portion of the proximal member that slidingly receives thesleeve may include au outer portion of the proximal member. The secondend portion of the sleeve may be biased against the proximal member.

In one embodiment proximal member is located within the sleeve.

The proximal member may form a part of a securing arrangement configuredto substantially fix the axial extent of the sleeve located between thedistal member and the proximal member at a desired length.

The sleeve may extend from the proximal member, around the distalmember, and has a return section outside of the proximal member, thereturn section providing the proximal gripping portion.

In one embodiment the distal member comprises a distal ring which may bean ring.

The distal ring may be formed of an elastomeric material.

In one embodiment the proximal member comprises a proximal ring whichmay be an O-ring.

The proximal ring may be relatively rigid with respect to the distalring.

In one embodiment the sleeve is of a pliable material.

The wound protector and retractor device may comprise a guide member fora proximal portion of the sleeve.

The sleeve may extend between the guide member and the proximal member.

The guide member may comprise a receiver for the proximal member. Forexample, the guide member may have an inwardly facing recess defining areceiver for the proximal member. In one case the proximal membercomprises a proximal ring and the recess has a shape which iscomplementary to that of the proximal ring, for example the recess maybe substantially C-shaped in transverse cross section.

In another embodiment a lock may be provided for locking the guidemember to the proximal member. The guide member may he engagable withthe proximal member to provide the lock.

In some cases the guide member may be an interference fit with theproximal member.

In one embodiment, on retraction of an incision the sleeve defines anexcess sleeve portion extending between the proximal member and thegripping portion.

The excess sleeve portion may be removed. Alternatively the excesssleeve portion is inserted through the retractor and in this case maydefine an organ retainer.

Alternatively the excess sleeve portion is configured to form a sealsuch as a forearm seal or an instrument seal.

The seal may comprise an iris valve.

In one embodiment the device comprises a guide member for a proximalportion of the sleeve and the excess sleeve material is mounted to theguide member. The excess sleeve material together with the guide membermay define a chamber. The chamber may have an inflation port. In onecase, on inflation, the chamber defines a seal for an object such as asurgeon's forearm or an instrument shaft.

In one embodiment the device comprises a first proximal mounting memberand a second proximal mounting member between which at least portion ofa sleeve extends. The first and second mounting members may be movablerelative to one another.

The mounting members may be movable axially relative to one anotherand/or the mounting members are rotationally movable relative to oneanother,

In one arrangement the mounting members are movable relative to oneanother to configure at least portion of the proximal portion of thesleeve to form a seal. The mounting members may be movable to twist thesleeve to form an iris.

In one embodiment the device comprises a biassing member for biassingthe seal into a desired configuration such as a closed configuration.

The biassing member may be a spring such as a coil spring.

In one embodiment the device further comprises a lock for locking thefirst and second mounting members together.

The second mounting member may be engagable with the first mountingmember to provide the lock. The lock may be provided by snap fittingengagement between the mounting members. Alternatively one mountingmember is an interference fit with the other mounting member to providethe lock.

In one case the sleeve which extends between the mounting members isproximal portion of the retracting sleeve.

In another case the sleeve which extends between the mounting members isa connecting sleeve which is separate from the retracting sleeve.

The first mounting member may comprise a ring member.

The second mounting member may comprise a ring member.

In one embodiment the wound protector and retractor device furtherincludes a valve. The valve may be attached to the retractor device.

In one case the valve is attached to the proximal portion of the sleeve.

In another case a connector is provided between the device and thevalve. The connector may comprise a connector sleeve. The connectorsleeve may be of substantially fixed length.

In one embodiment a flexible joint is provided between the valve and thedevice.

In another embodiment a malleable joint is provided between the valveand the device. In this case the valve may be offset with respect to thelongitudinal axis of the wound retractor.

In one embodiment the malleable joint is provided by a malleableconnecting sleeve section. The malleable connecting sleeve section maybe of corrugated configuration.

In one embodiment the valve is a lip seal.

Alternatively the valve is an iris seal.

The valve may be a forearm seal or an instrument seal.

In one embodiment the device comprises a release arrangement forreleasing the device from a retracting configuration. The releasearrangement may comprise a pulling device. The pulling device may becoupled to the distal member. The pulling device may comprise a pullcord or a ribbon.

In another aspect the invention provides a wound protector and retractordevice comprising:

-   -   a longitudinal axis;    -   a distal member;    -   a proximal member; and    -   a sleeve extending at least between the distal member and the        proximal member,    -   the sleeve, on retraction of an incision, defining an excess        sleeve portion extending proximally from the proximal member.

In one embodiment the excess sleeve portion is configured to form a sealsuch as a forearm seal or an instrument seal. The seal may comprise aniris valve.

In a further aspect the invention provides a wound protector andretractor device comprising:

-   -   a longitudinal axis;    -   a distal member;    -   a proximal member; and    -   a sleeve extending at least between the distal member and the        proximal member,    -   the device further comprising a first proximal mounting member        and a second proximal mounting member between which at least        portion of a sleeve extends.

The first and second mounting members may he movable relative to oneanother. The mounting members may be movable axially relative to oneanother and/or the mounting members are rotationally movable relative toone another. In one case the mounting members are movable relative toone another to configure at least portion of the proximal portion of thesleeve to form a seal. The mounting members may be movable to twist thesleeve to form an iris. The device may comprise a biassing member forbiassing the seal into a desired configuration such as a closedconfiguration.

In another aspect the invention provides a surgical device comprising awound retractor, a valve and a connector between the wound protector andthe valve, the wound retractor comprising:

-   -   a longitudinal axis;    -   a distal member;    -   a proximal member; and    -   a sleeve extending at least between the distal member and the        proximal member.

The connector may comprise a connector sleeve which may be ofsubstantially fixed length. The connector may comprise a flexible jointbetween the valve and the retractor. Alternatively the connectorcomprises a malleable joint between the valve and the retractor. Thevalve may be offset with respect to the longitudinal axis of the woundretractor. The malleable joint is provided by a malleable connectingsleeve section. The malleable connecting sleeve sections may be ofcorrugated configuration.

In another aspect the invention provides a method for retracting anincision comprising the steps of:

-   -   making an incision in a patient;    -   providing a wound retractor comprising a longitudinal axis, a        distal member, a proximal member, and a sleeve extending at        least between the distal member and the proximal member, the        sleeve having a proximal gripping portion;    -   inserting the distal member through the incision such that the        sleeve extends through the incision and the proximal member is        located outside of the incision;    -   gripping the gripping portion of the sleeve and pulling the        sleeve upwardly to shorten an axial extent of the sleeve located        between the distal member and the proximal member.

In one embodiment, on release of the gripping portion the shortenedaxial extent of the sleeve between the distal member and the proximalmember is substantially maintained.

The sleeve may be fixed to the proximal member at a first end portionand extending over the proximal member at a second end portion, and themethod comprises moving the sleeve over the proximal member as thesleeve is pulled upwardly to shorten the axial extent of the sleevelocated between the distal member and the proximal member. The methodmay comprise the step of moving the sleeve relative to the proximalmember including sliding a portion of the sleeve against a radiallyouter portion of the proximal member.

In one embodiment a portion of the sleeve located between the distalmember and the proximal member includes two material layers. The sleevemay be wrapped around the distal member to form the two material layers.

The method may comprise sealing the wound retractor, for example byattaching a seal to the wound retractor, by releaseably mounting a sealto the wound retractor. A seal may be mounted a proximal end of thewound retractor. A seal may be mounted to a proximal end of the sleeve.

In one case the retractor comprises a mounting member and the, seal isattached to the mounting member.

In one embodiment the seal is attached to the proximal end of the woundretractor using a connector,

The connector may be a connecting sleeve. The connector may be at leastpartially of a flexible material. Alternatively the connector is atleast partially of a malleable material and the method may comprise thestep of manipulating the connector into a desired configuration. In onecase the desired configuration is a configuration in which the seal isoffset from the longitudinal axis of the wound retractor.

In one embodiment the method comprises pulling the sleeve upwardly toprovide an excess sleeve portion extending proximally of the woundretractor. In one case the method comprises the step of cutting away theexcess sleeve portion. In another case the method comprises the step ofinserting the excess sleeve portion through the retractor. The excesssleeve material may be inserted through the retractor providing an organretainer.

In another case the method comprises the step of manipulating the excesssleeve portion to provide a seal.

In one embodiment the retractor comprises a proximal mounting member andthe excess sleeve portion is attached to the mounting member.

In another embodiment the excess sleeve portion forms, with the mountingmember, a chamber. The chamber may have an inflation port and the methodcomprises inflating the chamber to provide a seal.

The seal may be a lip seal or an iris seal.

In one embodiment the wound retractor is sealed with a forearm seal.

In another embodiment the wound retractor is sealed with an instrumentseal.

In one case the incision is of a size to receive an instrument, whenretracted.

In another case the incision is of a size to receive a forearm, whenretracted.

In a further case the incision is of a size to provide a site for opensurgery, when retracted.

According to the invention there is provided a medical devicecomprising:

-   -   a retractor member comprising a distal portion for insertion        through an incision made in a patient, and a proximal portion        for extending from the incision and outside of the patient;    -   a distal member associated with the distal portion of the        retractor member;    -   a proximal member associated with the proximal portion of the        retractor member;    -   the retractor member being axially movable relative to the        distal member to draw the proximal and distal members towards        one another thereby shortening the axial extent of the retractor        member between the proximal and distal members.

In one embodiment the retractor member comprises a sleeve member. Thesleeve member preferably extends around the distal member.

In one embodiment the distal member is a ring member such as a resilientring member, for example, an O-ring.

In one embodiment the proximal member is connected to the retractormember. The proximal member may be a ring member.

In one embodiment the sleeve member is of a pliable material.

In one arrangement the sleeve extends from the proximal member, aroundthe distal member and has a return section outside of the proximalmember.

The return section may have a handle member such as a ring member.

In one embodiment the device comprises a guide member.

The retractor member may extend between the guide member and theproximal member.

The guide member may comprise a receiver for the proximal member.

The guide member may comprise a guide ring-receiving member.

The sleeve return section may be configured to provide an integral valvemember. In this case the sleeve return section may be twisted to providean iris valve.

In another embodiment the sleeve return section is mounted to the guidemember.

The sleeve return section may be extended into the opening defined bythe sleeve member.

The device may comprise a lock for locking the guide member to theproximal member. Typically the guide member is engagable with theproximal member to provide the lock.

The guide member may be an interference fit with the proximal member.

In one embodiment of the invention the device includes a valve, such asan iris-type valve.

In one embodiment the device comprises a biassing member for biassingthe valve into a desired position such as the closed position.

In one arrangement the device comprises a guide member locatedproximally of the proximal member and a biassing means is providedbetween the proximal member and the guide member. The biassing means maycomprise a spring such as a coil spring.

In one embodiment a sleeve member extends between the proximal memberand the guide member and the biassing means is located around thesleeve. The sleeve member may be an extension of the retractor member.

In one embodiment the device comprises a release member for releasingthe device from an incision. The release member may comprise an elongatemember such as a pull ribbon or string extending from a distal end ofthe device.

The release member may extend from the distal member.

In one embodiment the valve is located or locatable proximal of theproximal member. A pliable material may be provided between the valveand the proximal member. The pliable material may comprise a proximalextension of the retractor member.

In one embodiment the pliable material comprises a sleeve section.

In another embodiment the valve is a lip seal.

The invention also provides a method for retracting an incisioncomprising the steps of:

providing a device comprising a retractor member having a distal portionand a proximal portion, a distal member associated with the distalportion and a proximal portion associated with the proximal portion;

inserting the distal member and the distal portion of the retractormember through an incision made in a patient; and

pulling the retractor member axially relative to the distal member todraw the proximal and distal members towards one another therebyshortening the axial extent of the retractor member between the proximaland distal members and retracting the incision.

BRIEF DESCRIPTION OF THE DRAWING

The invention will be more clearly understood from the followingdescription of some embodiments thereof, given by way of example only,with reference to the accompanying drawings, in which:

FIG. 1 is a perspective view of a retractor according to the invention;

FIG. 2 is a cross sectional view of the device of FIG. 1

FIGS. 3 and 4 are perspective views illustrating the formation of thedevice of FIGS. 1 and 2;

FIGS. 5 and 6 are cross sectional views of FIGS. 3 and 4 respectively;

FIGS. 7 and 8 are perspective views illustrating the use of the device;

FIGS. 9 and 10 are cross sectional views illustrating the method of useof the device;

FIG. 11 is a cross sectional view of another device according to theinvention in a configuration ready for use;

FIG. 12 is a perspective view of the device of FIG. 11 with a distalportion inserted through an incision;

FIG. 13 is a cross sectional view of the device of FIG. 11 with a distalportion inserted through an incision;

FIG. 14 is a cross sectional view of the device of FIG. 11 in use withan incision retracted;

FIG. 15 is a perspective view of the device in the configuration of FIG.14;

FIG. 16 is a perspective view of the device in situ with an excesssleeve portion being removed;

FIG. 17 is a cross sectional view of the device in situ with an excesssleeve portion extending back into the incision;

FIG. 18 is a perspective view of the device in situ with a excess sleeveportion being twisted;

FIG. 19 is a perspective view similar to FIG. 18 with the excess sleeveportion further twisted to provide an iris valve;

FIG. 20 is a cross sectional view of another device according to theinvention in situ;

FIG. 21 is a cross sectional view of the device of FIG. 20 with anexcess sleeve portion mounted to a guide member;

FIG. 22 is a cross sectional view of the device of FIG. 21 with theexcess sleeve portion inflated to provide an integral everting accesspart;

FIG. 23 is a perspective view of another retractor according to theinvention incorporating a release device;

FIG. 24 is a cross sectional view of the retractor of FIG. 23;

FIG. 25 is a perspective view illustrating the formation of the deviceof FIG. 23;

FIG. 26 is a cross sectional view of the device in the configuration ofFIG. 25;

FIG. 27 is a cross sectional view of the retractor of FIGS. 23 to 26, inuse:

FIG. 28 is a cross sectional view of the retractor of FIGS. 23 to 27illustrating the operation of a release device;

FIG. 29 is a perspective view of another device according to theinvention in an insertion configuration;

FIG. 30 is a perspective view of the device of FIG. 29 in position in anincision;

FIG. 31 is another perspective view of the device of FIG. 30 in anotherconfiguration;

FIG. 32 is another view of the device of FIG. 31 with an outer portionsevered and a valve being formed;

FIG. 33 is a view of the device of FIG. 32 with the valve closed;

FIG. 34 is a perspective view of another device similar to the device ofFIGS. 29 to 33 with a valve closed:

FIG. 35 is a cross sectional view of the device of FIG. 34;

FIG. 36 is a perspective view of another device similar to the device ofFIGS. 29 to 33 incorporating a biassing means in an insertedconfiguration;

FIG. 37 is another perspective view of the device of FIG. 36 in aretracting configuration;

FIG. 38 is a perspective view of the device of FIG. 37 in anotherconfiguration and excess sleeve being removed;

FIG. 39 is a perspective view of the device of FIG. 38 with a valveclosed;

FIG. 40 is a perspective view of the device of FIG. 39 with a valvepartially open;

FIGS. 41A-41D are side views of the device of FIG. 39, showing an objectinserted through the valve;

FIG. 42 is a perspective view of another device according to theinvention;

FIG. 43 is a cross sectional view of the device of FIG. 42 in positionin an incision;

FIG. 44 is a cross sectional view of the device of FIG. 43 with anobject extending therethrough;

FIG. 45 is a cross sectional view similar to FIG. 44 with an objectoffset from a longitudinal axis of the device;

FIG. 46 is a cross sectional view of another device according to theinvention on insertion into an incision;

FIG. 47 is a cross sectional view of the device of FIG. 46 with anincision retracted;

FIGS. 48 and 49 are cross sectional views of the device of FIG. 47showing the formation of an iris valve;

FIG. 50 is a cross sectional view of another access port;

FIG. 51 is a cross sectional view of the port of FIG. 50 with anInstrument in position;

FIGS. 52 to 55 are cross sectional views of another access port;

FIGS. 56 and 57 are cross sectional views of a further access port;

FIGS. 58 and 59 are cross sectional views of another access port;

FIGS. 60 to 62 are cross sectional views of a further access port;

FIGS. 63 to 66 are cross sectional views of another access port;

FIGS. 60 to 72 are cross sectional views of another access port of theinvention.

DETAILED DESCRIPTION

Referring to the drawings, and initially to FIGS. 1 to 10 thereof thereis illustrated a device 1 comprising a retractor member provided by asleeve 2, a distal member provided by a distal ring 3 of resilientmaterial such as an O-ring and a proximal member provided by a proximalring 4 which may also be an O-ring.

The sleeve 2 is of any suitable material such as of pliable plasticsfilm material and comprises a distal portion 5 for insertion through anincision 6, in this case made in a patient's abdomen 7, and a proximalportion 8 for extending from the incision 6 and outside of the patient.

In this case the distal ring 3 is not fixed to the sleeve 2 but ratherthe sleeve is led around the ring 3 and is free to move axially relativeto the distal ring 3 somewhat in the manner of a pulley. The proximalring 4 is fixed to the sleeve 2, in this case at the proximal inner endthereof. The sleeve 2 terminates in a handle or gripping portion whichin this case is reinforced by a gripping ring 15.

To configure the retractor device according to the invention a sleeve 2is first provided with the gripping ring 15 fixed at one end and theproximal ring 4 fixed at the other end [FIGS. 3, 5]. The distal ring 3is then placed over the sleeve 2 as illustrated in FIGS. 4 and 6. Thegripping ring 15 is then used to manipulate the sleeve 2 so that thesleeve 2 is folded hack on itself into the configuration of FIGS. 1 and2 in which the gripping ring 15 is uppermost. The sleeve extends fromthe proximal ring 4 and the distal ring 3 is contained between inner andouter layers 2 a, 2 b of the sleeve 2. The device is now ready for use.

The resilient distal ring 3 is scrunched up and inserted through theincision 6 with the distal end 5 of the sleeve 2 as illustrated in FIG.4. The sleeve 2 is then pulled upwardly in the direction of the arrows Ain FIGS. 8 to 10. On pulling of the sleeve 2 upwardly the outer layer 2b is pulled up while the inner layer 2 a is drawn around the proximalring 3. This results in shortening the axial extent between the proximalring 4 and the distal ring 3, tensioning the sleeve and applying aretraction force to the margins of the incision 6. The system appears tobe self locking because when tension is applied to the sleeve 2 and thepulling force is released the rings 3, 4 remain in position with aretraction force applied. Frictional engagement between the layers ofthe sleeve in this configuration may contribute to this self locking.

As the incision is being retracted the margins are also protected by thesleeve. On retraction, an access port is provided, for example for asurgeon to insert his hand and/or an instrument to perform a procedure.The device may be used as a retractor in open surgery or as a base for avalve/seal to allow it to be used in hand assisted laparoscopic surgeryor for instrument or hand access generally.

Excess sleeve portion 20 outside the incision may, for example, becut-away.

The retractor is suitable for a range of incision sizes and is easilymanufactured. It is also relatively easy to manipulate, in use, it notonly retracts but also protects the incision.

Referring now to FIGS. 11 to 19 there is illustrated another device 50according to the invention which is similar to the device describedabove with reference to FIGS. 1 to 10 and like parts are assigned thesame reference numerals. In this case the device comprises a guidemember 51 for the proximal ring 4. The guide member 51 is in the form ofan annular ring member with an inwardly facing C-shaped groove 52 whichis sized to accommodate the ring 4 as illustrated. The outer layer ofthe sleeve 2 is interposed between the ring 4 and the guide 51 tofurther control the pulling of the sleeve and thereby furthercontrolling the application of the retraction force. The guide 51 alsoassists in stabilising the proximal ring 4. The use of the device 50 isillustrated in FIGS. 12 to 15 is similar to that described above.

Any suitable guide such as the ring 51 may be used to assist inretaining/stabilising the proximal ring 4 in a desired position duringpulling up of the sleeve to retract the incision. The guide may belocated proximal of the ring 4.

The guide member provides a monitoring member to which devices such asvalves may be attached.

Referring to FIG. 16, it will be noted that in one case the excesssleeve portion 20 may be cut-away.

Referring to FIG. 17, in this case the excess sleeve portion is inverted60 into the incision. In this configuration it may act as an organretractor, or provide the surgeon with an open tunnel to work in.

Referring to FIGS. 18 and 19 in this case the excess sleeve portion istwisted to form an iris diaphragm valve 65.

In the embodiment illustrated in FIGS. 20 to 22 a device 70 according tothe invention has an integral seal/valve 71. The device 70 is similar tothat described above with reference to FIGS. 11 to 19 and like parts areassigned the same reference numerals. In this case the guide member 50has an outer groove 75 to receive the gripping ring 15 as illustrated inFIGS. 21. The excess sleeve portion 20 is folded out and down and thegripping ring 15 is engaged in the groove 75 to provide an air tightseal. In this configuration the excess sleeve may be inflated through aninflation port 76 [FIG. 22] to provide an integral access valve 71. Thevalve may be used to sealingly engage a hand, instrument or the likepassing therethrough. The inflated sleeve portion defining the valve isevertable on passing an object therethrough.

Referring to FIGS. 23 to 28 there is illustrated another retractor 80according to the invention which is similar to the retractors describedabove and like parts are assigned the same reference numerals. In thiscase the retractor 80 has a release mechanism which in this case isprovided by a release cord or ribbon 81 which is coupled at one end 82to the inner ring 3 and terminates in an outer free end 83 which may begrasped by a user. The ribbon 81, on assembly, is led through the gapbetween the proximal ring 4 and the outer guide member 51 so that it ispositioned between the ring 4 and the guide member. The ribbon 81facilitates release of the self locked sleeve in the in-useconfiguration sited in an incision. Pulling on the ribbon 61 pulls onthe inner ring 3, allowing the ring 3 to be released from the inner wallof the incision to thereby release the device. The flexibility of thering 3 facilitates this movement.

The advantage of this arrangement is that a user can readily release thedevice from its self locked retracting configuration.

Referring to FIGS. 29 to 33 there is illustrated another device 90according to the invention in which parts similar to those of thedevices described above are assigned the same reference numerals. Inthis case the device 90 has a lower guide ring 51 for the proximal ring4 and an outer guide assembly provided by an upper guide ring 91 and asecond proximal ring 92 between which the sleeve 2 is led. In allrelevant embodiments the upper guide such as the ring 91 may provide asecond mounting member located proximally of the first guide member suchas the ring 51 which also provides a mounting member. The device is usedto first retract an incision as described above. During this phase theouter guide assembly is conveniently external of the guide member 51 andproximal ring 4. Indeed, it may be completely detached from the sleeve 2and subsequently coupled to the sleeve 2 at an appropriate stage such aswhen the incision is retracted as illustrated in FIG. 30. The outerguide assembly is then moved downwardly towards the incision asillustrated in FIG. 31. This may be achieved while pulling the sleeve 2upwardly. When the guide assembly is adjacent to the guide member 51excess sleeve length may be severed as illustrated in FIG. 32. Bytwisting the guide assembly relative to the guide member 51 the sleeve 2is twisted, closing down the lumen of the sleeve 2 and forming an iristype access valve 95 as illustrated in FIG. 33. In this way a sealedaccess port is provided for hand arid/or instrument access through theincision.

It will be appreciated that while reference has been made to an incisionmade by a surgeon the devices of the invention may be applied forretraction of any opening such as a body opening.

Referring to FIGS. 34 and 35 there is illustrated another retractordevice 100 according to the invention which is similar to the device ofFIGS. 29 to 33 and like parts are assigned the same reference numerals.In this case a releasable lock is provided to maintain the access valve95 closed. For interlocking, in this instance the upper guide ring 91 isan interference fit with the lower guide ring 51. Various other lockingarrangements may be used such as a screw threaded or bayonet typeengagement, magnets, clips and the like.

Referring to FIGS. 36 to 41D there is illustrated another retractordevice 110 according to the invention which is similar to the device ofFIGS. 29 to 33 and like parts are assigned the same reference numerals.In this case the device incorporates a biassing means to bias anintegral valve into a closed position. The biassing means is in thiscase provided by a coil spring 111 which is located around the sleevebetween the guide rings 51, 91. In use, the device is used in a similarmanner to the device of FIGS. 29 to 33 except that on movement of theupper guide ring 91 downwardly the spring 111 also moves downwardlytowards the lower guide ring 51, initially into the position illustratedin FIG. 38. Excess sleeve material may be removed at this stage. Thespring 111 is tensioned as the upper ring 91 is rotated while pushingthe upper ring 91 downwardly. The sleeve material between the two rings51, 91 is twisted, forming an iris type valve 112 as illustrated in FIG.39. To open the valve 112 to pass an object such as an instrument, hand,arm or the like therethrough a downward force may be applied to push theupper ring 91 towards the lower ring 51 against the biassing of thespring.

This configuration is illustrated in FIG. 40. When the object isinserted the upper ring member 91 is released, allowing the valve toclose around the object. The operation of the device 110 will be readilyapparent from FIGS. 41A to 41D. In FIG. 41A the valve 112 is illustratedin a closed resting configuration. FIG. 41B shows the application of adownward force to open the valve 112. An object such as an instrument113 is shown inserted through the open valve 112 in FIG. 41C. In FIG.41D the downward pressure on the upper ring 91 is released allowing thevalve 112 to close around the object 113.

Referring now to FIGS. 42 to 45 there is illustrated another device 120according to the invention which has some aspects similar to the deviceof FIGS. 11 to 18 and like parts are assigned the same referencenumerals. In this case the device has a lip seal 121. The lip seal 121is provided by a membrane with a central aperture 122 through which anobject 123 such as an instrument is passed. The lip seal 121 is locatedon the sleeve 2 proximally of the guide ring 51 such that a proximalflexible sleeve section 125 is provided. This sleeve section 125 is veryuseful in facilitating offset movements of the object 123 as illustratedin FIG. 45. The sleeve section 125 accommodates movement of the object123 whilst maintaining sealing engagement between the lip seal 121 andthe object 123. It will be appreciated that this feature, as withseveral other features described above may be utilised in associationwith other constructions of wound protector/retractors and access partsgenerally other than those illustrated in the drawings.

Referring to FIGS. 46 to 48 there is illustrated another device 130according to the invention which has some features similar to those ofFIGS. 11 to 15, like parts being assigned the same reference numerals Inthis case the sleeve has a proximal section external of the wound whenthe device is in the retracting configuration. This proximal sleevesection comprises a first portion 131 extending from the guide ring 51and a second portion 132 extending from the first portion 131. Thesecond portion 132 is defined between two spaced-apart iris rings 134,135. It will be noted that the iris rings 134, 135 have engagementfeatures such as projections and grooves for interengagement onassembly. The iris ring 134 also has an engagement element, in this caseprovided by a groove 137 for engagement on assembly with a correspondingengagement element of the guide ring 51 which in this case is providedby a projection 138.

The device is fitted as described above to retract an incision, leavingthe first and second sleeve portions 131, 132 extending proximally. Thefirst sleeve portion 131 is redundant and can be removed or scrunched upon assembly of the first iris ring 134 to the guide ring 138 asillustrated in FIG. 48. The second or upper iris ring 135 is thenrotated to twist the sleeve section 132 to form an iris-type seal asillustrated in FIG. 49. The iris ring 135 is engaged with the iris ring134 as illustrated to maintain the valve closed.

In some of the embodiments described above a valve 829 is mounteddirectly to a retractor base 811. It is possible to provide a flexiblecoupling between the retractor 811 and the valve 829. For example, asillustrated in FIGS. 50 and 51 such a flexible coupling is provided by alength of flexible sleeve 830 extending between the retractor 811 andthe valve 829. The flexible sleeve 830 may be formed by excess retractorsleeve material attached to the valve 829.

In a further embodiment of the invention as illustrated in FIGS. 52 to57 a valve 860 may be coupled to the retractor 811 in such a way as tofacilitate a flexible joint therebetween. For example, a fixed lengthsleeve 862 may extend between an outer proximal ring 863 of theretractor 811 and the valve 860. Excess sleeve material 864 from theretractor 811 may pass up through the valve 860. The valve 860 may bepushed down and the excess sleeve pulled up to firmly lock the baseretractor 811 in the incision. Excess sleeve material 864 may becut-away and removed, if desired. The flexible sleeve 864 allows theinstrument to tilt as illustrated in FIG. 57 without compromising thevalve seal to the shaft of the instrument/object 814.

As illustrated in FIGS. 58 and 59 a spring 867 may be provided betweenthe valve 860 and the retractor proximal ring 863 for more controlledflexibility.

Referring now to FIGS. 60 to 62 another modular system is illustrated inwhich a valve 870 is releasably mounted to a retractor 811. Theretractor 811 may have a proximal ring 871 with a recess 872 to receivethe valve 870. An instrument shaft 814 can readily pass through thevalve 870 and retractor 811. At least a section 873 of the shaft 814 canbe bent or steered almost immediately distal of the retractor.

Referring now to FIGS. 63 to 66 any suitable valve 880 may be coupled toa retractor 811 using excess sleeve material 881 from the retractor 811.The valve 880 may be pulled upwardly to deploy the base retractor 811.The excess sleeve material 881 provides a flexible neck whichfacilitates easy introduction, of objects such as an instrument 883,even one having a bent shall (FIG. 119). As illustrated in FIG. 120 suchan arrangement also facilitates additional instrument reach by allowingthe valve 880 to be moved closer to the base retractor 811.

Referring to FIGS. 67 to 72 there is illustrated another access portcomprising a wound protector and retractor device 811 and a valve 900.The valve 900 is connected to an outer guide ring 901 of the retractordevice 811 by a sleeve 902 which in this case is of malleable materialof corrugated configuration somewhat in the manner of the bendable hingeportion of a bendable drinking straw. The sleeve 902 may be pre-shapedto be offset from the longitudinal axis of the retractor to facilitateease of insertion of an instrument or the like. The corrugated sleeve902 may be compressed as illustrated in FIG. 68 to provide a low profileto facilitate outlining any of excess retractor sleeve as illustratedin. FIGS. 69 and 70. Thereafter, the corrugated sleeve 902 can beextended/elongated and is readily manipulated into a desiredconfiguration. Because the sleeve 902 is malleable it will retain adesired bent shape, even when the abdomen is pressurised. Any excessretractor sleeve material 905 may be cut-away as illustrated or used asdescribed above.

In this context the term “malleable” is used to denote ate element whichis capable of being manipulated into a desired position and/ororientation, and which retains this manipulated position and/ororientation under the typical stresses and strains applied when used foran intended purpose with a patient, for example during partial insertionof a laparoscopic instrument.

The access ports of the invention can be used in a number of ways. Inone method the retractor is used as described above, the distal innerring being inserted into an incision, the outer ring being slid tocontrollably radially expand the incision. The retractor may then belocked in position. If necessary, the outer ring can be moved furtherdownwardly to create a larger incision.

In some arrangements an instrument may be bent manually outside the bodyand the bent instrument is delivered through the access port to readilyaccess the operative site.

In a further embodiment an instrument is inserted into the access portand the surgeon uses the abdominal wall itself to bend the instrumentand then insert the bent section further into the abdomen.

In all cases the sleeve may be gripped by gripping a valve or otherelement mounted thereto.

The access ports of the invention have at least some of the followingadvantages:

Controlled Radial Expansion

-   1. Greater access using smaller incision-   2. Can vary incision size as need be (e.g. specimen removal during    lap coli.)    Greater Sealing Capabilities-   1. No gas leakage from the wound margins-   2. Cannot be inadvertently pulled out of the incision-   3. Will seal any incision and never require secondary sealing method    (suture, Hasson port, etc.)    Eliminate Intra-Abdominal Profile-   1. Gives back more working space in the abdomen (critical in pelvic    surgery)-   2. Perineal access for operations such as Radical Prostatectomy.    Protection of Wound from Infection and Cancer Seeding-   1. Tight seal with no “chimney stack” effect-   2. Upon removal all areas of potential contamination are isolated    from the incision    Reduced Extra-abdominal Profile-   1. Will increase the effective working length of an instrument-   2. Greater working area outside the abdomen    Increase the Freedom of Movement of Conventional Laparoscopic    Instruments

The invention is not limited to the embodiments hereinbefore described,with reference to the accompanying drawings, which may be varied inconstruction and detail.

The invention claimed is:
 1. A surgical device, comprising: a woundretractor, including: a distal member, a proximal member, and a woundretracting sleeve extending at least between the distal member and theproximal member, wherein the wound retractor is configured to retract awound opening as an axial extent of the wound retracting sleeveextending between the distal member and the proximal member isshortened; and a sealing assembly coupled to the wound retractor, thesealing assembly including: a sealing assembly sleeve, wherein thesealing assembly sleeve is pre-shaped such that at least a portion of alongitudinal axis of the sealing assembly sleeve is at an angle withrespect to a longitudinal axis of the wound retractor, and a sealcoupled to the sealing assembly sleeve, the seal being configured toprovide sealing engagement with an instrument inserted through the seal.2. The surgical device of claim 1, wherein a longitudinal axis of theseal is angled relative to the longitudinal axis of the wound retractor.3. The surgical device of claim 1, wherein the sealing assembly sleeveis movable relative to the wound retracting sleeve.
 4. The surgicaldevice of claim 1, wherein the seal is coupled to a proximal end of thesealing assembly sleeve.
 5. The surgical device of claim 1, wherein thesealing assembly includes an outer member mounted to the proximalmember.
 6. The surgical device of claim 5, wherein a diameter of theseal is smaller than a diameter of the outer member.
 7. The surgicaldevice of claim 5, wherein a diameter of the sealing assembly sleeve issmaller than a diameter of the outer member.
 8. A surgical device,comprising: a wound retractor, including: a distal member, a proximalmember, and a wound retracting sleeve extending at least between thedistal member and the proximal member, wherein the wound retractor isconfigured to retract a wound opening as an axial extent of the woundretracting sleeve extending between the distal member and the proximalmember is shortened; and a sealing assembly coupled to the woundretractor, the sealing assembly including: a sealing assembly sleeve,and a seal configured to provide sealing engagement with an instrumentinserted through the seal, the seal being coupled to the sealingassembly sleeve, wherein the sealing assembly sleeve is pre-shaped suchthat at least a portion of a longitudinal axis of the sealing assemblysleeve is at an angle with respect to a longitudinal axis of the woundretractor, and the seal is spaced apart from the proximal member.
 9. Thesurgical device of claim 8, wherein a longitudinal axis of the seal ispositioned at an angle relative to the longitudinal axis of the woundretractor by the pre-shaped sealing assembly sleeve.
 10. The surgicaldevice of claim 8, wherein the sealing assembly sleeve extends radiallyoutwardly away from the longitudinal axis of the wound retractor as thesealing assembly sleeve extends from the proximal member in a proximaldirection.
 11. The surgical device of claim 8, wherein the seal iscoupled to a proximal end of the sealing assembly sleeve.
 12. Thesurgical device of claim 8, wherein the seal includes a valve.
 13. Thesurgical device of claim 8, wherein the sealing assembly sleeve forms ahinge connection between the seal and the proximal member.
 14. Asurgical device, comprising: a wound retractor, including: a distalmember, a proximal member, and a wound retracting sleeve extending atleast between the distal member and the proximal member, wherein thewound retractor is configured to retract a wound opening as an axialextent of the wound retracting sleeve extending between the distalmember and the proximal member is shortened; and a sealing assemblycoupled to the wound retractor, the sealing assembly including: asealing assembly sleeve, and a seal coupled to the sealing assemblysleeve, the seal being configured to provide sealing engagement with aninstrument inserted through the seal, wherein a longitudinal axis of theseal is positioned at an angle relative to a longitudinal axis of thewound retractor by the sealing assembly sleeve.
 15. The surgical deviceof claim 14, wherein the sealing assembly sleeve extends radiallyoutwardly away from the longitudinal axis of the wound retractor as thesealing assembly sleeve extends from the proximal member in a proximaldirection.
 16. The surgical device of claim 14, wherein the seal iscoupled to a proximal end of the sealing assembly sleeve.
 17. Thesurgical device of claim 14, wherein the seal includes a valve portion.18. The surgical device of claim 14, wherein the sealing assembly sleeveforms a hinge connection between the seal and the proximal member. 19.The surgical device of claim 14, wherein the proximal member includes aninner ring member and an outer ring member, the inner ring member beingat least partially received in a recess of the outer ring member. 20.The surgical device of claim 14, wherein the seal is proximally spacedfrom the proximal member by the sealing assembly sleeve.